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IRCT20220212054002N3 IRCT 2023-08-14 Mansoura university External Oblique Intercostal Plane Block in Supra-umbilical Surgical Incisions EOIB External Oblique Intercostal Plane Block Versus rectus sheath Plane Block in Supra-umbilical Surgical Incisions; Randomized Controlled Double Blinded Clinical Trial 2023-07-22 anticipated 70 Complete https://irct.ir/trial/71962 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Enrolled patients will randomly allocated to group (EOIB) and group (RSB) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anesthesia by physician who will not involved in the study . The patients will be allocated to either group “EOIB”, who receive external oblique intercostal plane block , or group “RSB” who receive rectus sheath plane block , with general anesthesia, Blinding description: Anesthesiologist who will perform the block will not be blinded to group assignment. However, participant ,anesthesiologist responsible of the patient , and health care providers who collected the data will be blinded to group allocation. 4 Post operative pain control in super umbilical surgical incision. Intervention 1: Intervention group: A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an inplane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine1% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. Intervention 2: Intervention group: The rectus sheath block was performed bilaterally with real-time ultrasonographic guidance (HFL38x/13-6 MHz Linear Array Transducer; Sonosite M-Turbo™, Bothell, WA, USA) using a 22G (0.70 mm × 50 mm)Stimuplex® A insulated needle (B. Braun, Melsungen, Germany) via an in-plane approach to the rectussheath. 10 mL of 1% lignocaine, together with adrenaline 1:200,000, and 10 mL of 0.5% bupivacainewere deposited in the potential space between the rectus abdominis muscle and the posterior rectussheath bilaterally . A total of 30 mL of 1% lignocaine (200 mg) and 20 mL of 0.5% bupivacaine (100 mg)were administered. Yes - There is a plan to make this available What will be shared: all collected identified IPD When: 6 month after publication To whom: only available for people working in academic institutions Conditions: IPD and primary outcome Where to obtain: zenatddd@gmail.com How to obtain: email request Comments:
public Zenat Eldadamony
Algomhoria street
Mansoura Egypt 35511 +20 122 543 9066 zenatddd@gmail.com Mansoura university scientific Zenat Eldadamony Mohamed
Algomhoria street
Mansoura Egypt 35511 +20 100 726 8585 zenatddd@gmail.com Mansoura university Egypt American Society of Anesthesiologists (ASA) physical status grade I -II Scheduled to undergo elective supra-umbilical surgeries under GA (epigastric herniotomy- gastrectomy-open cholecystectomy- nephrectomy). 18 years 70 years Both Allergy to local anesthetics,, Infection at the site of injection, Coagulopathy, Chronic pain syndromes Prolonged opioid medication, Chronic liver disease , or chronic renal disease, cognitive impairment. K87 umbilical surgical incision Treatment - Other Treatment - Other Intervention group: A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an inplane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine1% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. Intervention group: The rectus sheath block was performed bilaterally with real-time ultrasonographic guidance (HFL38x/13-6 MHz Linear Array Transducer; Sonosite M-Turbo™, Bothell, WA, USA) using a 22G (0.70 mm × 50 mm)Stimuplex® A insulated needle (B. Braun, Melsungen, Germany) via an in-plane approach to the rectussheath. 10 mL of 1% lignocaine, together with adrenaline 1:200,000, and 10 mL of 0.5% bupivacainewere deposited in the potential space between the rectus abdominis muscle and the posterior rectussheath bilaterally . A total of 30 mL of 1% lignocaine (200 mg) and 20 mL of 0.5% bupivacaine (100 mg)were administered. POST OPERATIVE PAIN SCORE. Timepoint: 24 hours post operative. Method of measurement: VISUAL ANALUGE SCALE. Amount of postoperative morphine consumed. Timepoint: 24 hours post operative. Method of measurement: milligram. Amount of postoperative morphine consumed. Timepoint: 24 hours post operative. Method of measurement: milligram. Mansoura university hospital Approved 2023-08-06 Institutional Research Board Algomhorea street Mansoura Mansoura Egypt